KIRTLAND & PACKARD LLP Levin, Papantonio, Thomas, …

Case 1:19-cv-00212-LJO-SKO Document 1 Filed 02/12/19 Page 1 of 39

1 Michael Louis Kelly (SBN 82063)

mlk@ 2 Behram V. Parekh (SBN 180361)

3

bvp@ Ruth Rizkalla (SBN 224973)

4 rr@ KIRTLAND & PACKARD LLP

5 1638 S Pacific Coast Hwy

Redondo Beach, CA 90277 6 Tel: (310) 536-1000 / Fax: (310) 536-1001

7 Daniel A. Nigh

8 Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. 316 S. Baylen Street, Suite 600

9 Pensacola, FL 32502 Phone: (850) 435-7013

10 Fax: (850) 436-6013 11 Email: dnigh@

12 Attorneys for Plaintiff

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14

UNITED STATES DISTRICT COURT FOR THE

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16

EASTERN DISTRICT OF CALIFORNIA

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18 Kevork Avedikian, an Individual,

Case No. 1:19-at-121

19

Plaintiffs,

COMPLAINT AND DEMAND FOR

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v.

JURY TRIAL

21

JURY TRIAL DEMANDED

Zhejiang Huahai Pharmaceutical Co., Ltd,

22 Prinston Pharmaceutical, Inc. dba Solco

Healthcare US, LLC, Solco Healthcare US, 23 LLC, and Huahai U.S., Inc.

24

Defendants.

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26

27

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1 COMPLAINT AND DEMAND FOR JURY TRIAL

Case 1:19-cv-00212-LJO-SKO Document 1 Filed 02/12/19 Page 2 of 39

1 I. INTRODUCTION

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3

Plaintiff brings this Complaint as a result of Plaintiff's development of Stomach Cancer,

4 as a result of taking an adulterated, misbranded, and unapproved medication designed,

5 manufactured, marketed, distributed, packaged, and sold by Defendants.

6

7

II. PARTIES

8

I. PLAINTIFF

9 1. At all relevant times, Plaintiff Kevork Avedikian was and is a resident of the City of Fresno,

10

County of Fresno, in the State of California.

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12

II. DEFENDANTS

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1. Active Pharmaceutical Manufacturers

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i. Zhejiang Huahai Pharmaceutical Co., Ltd

15 2. Defendant Zhejiang Huahai Pharmaceutical Co., Ltd. is a Chinese corporation, with its

16 principal place of business at Xunqiao, Linhai, Zhejiang 317024, China. The company also

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has a United States headquarters located at 2009 Eastpark Blvd., Cranbury, NJ 08512.

19 3. Zhejiang Huahai Pharmaceutical Co., Ltd. is the parent company of subsidiaries Prinston

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Pharmaceutical Inc., Solco Healthcare, LLC, and Huahai U.S., Inc.

21 4. The valsartan-containing drugs made by Zhejiang Huahai Pharmaceutical Co. Ltd. are

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distributed in the United States by three companies: Major Pharmaceuticals; Teva

23 Pharmaceutical Industries, Ltd.; and Solco Healthcare.1

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27 1 ;

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2 COMPLAINT AND DEMAND FOR JURY TRIAL

Case 1:19-cv-00212-LJO-SKO Document 1 Filed 02/12/19 Page 3 of 39

1

2. Drug Manufacturers

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i. Prinston Pharmaceutical, Inc. dba Solco Healthcare US, LLC

3 5. Defendant Prinston Pharmaceutical, Inc., dba Solco Healthcare US, LLC2 is a Delaware

4 corporation, with its principal place of business at 2002 Eastpark Blvd., Cranbury, New Jersey

5 08512.3

6

7 6. Solco Healthcare U.S., LLC is a fully owned subsidiary of Prinston Pharmaceutical, Inc. and

8

Zhejiang Huahai Pharmaceutical Co, Ltd.

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ii. Solco Healthcare US, LLC

10 7. Defendant Solco Healthcare US, LLC is a Delaware corporation, with its principal place of

11 business located at 2002 Eastpark Boulevard, Suite A, Cranbury, New Jersey 08512.

12

8. Solco Healthcare US, LLC is a fully owned subsidiary of Prinston Pharmaceutical, Inc. and 13

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Zhejiang Huahai Pharmaceutical, Ltd.4

15 3. Other Entities

16 ii. Huahai U.S., Inc.

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18 9. Defendant Huahai U.S., Inc. is a New Jersey corporation, with its principal place of business

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at 2001 (and 2002) Eastpark Boulevard, Cranbury, NJ 08512.5

20 10. Defendant Huahai US Inc. is a subsidiary of Zhejiang Huahai Pharmaceutical Ltd., Co.

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22

III. JURISDICTION AND VENUE

23 11. This court has subject matter jurisdiction over this action pursuant to 28 U.S.C. ? 1332,

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because there is complete diversity of citizenship between Plaintiff and the Defendants, and

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26 2

27 3 . 4 .

28 5 .

3 COMPLAINT AND DEMAND FOR JURY TRIAL

Case 1:19-cv-00212-LJO-SKO Document 1 Filed 02/12/19 Page 4 of 39

1

because Plaintiff allege an amount in controversy in excess of $75,000, exclusive of interest

2

and costs.

3 12. The court has personal jurisdiction over Defendants because at all relevant times they have

4 engaged in substantial business activities in the State of California. At all relevant times

5

Defendants transacted, solicited, and conducted business in California through their 6

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employees, agents, and/or sales representatives, and derived substantial revenue from such

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business in California.

9 13. Venue is proper in this district pursuant to 28 U.S.C. ? 1391(a) because a substantial portion

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of the wrongful acts upon which this lawsuit is based occurred in this District. Venue is also

11 proper pursuant to 28 U.S.C. ? 1391(c), because Defendants are all corporations that have

12 substantial, systematic, and continuous contacts in the State of California, and they are all

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subject to personal jurisdiction in this District.

15 IV. PLAINTIFF'S MEDICATION

16 14. The medication in question in this case is a drug that Defendants marketed and sold under the

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name "valsartan."

19 15. Valsartan is a generic version of the brand-name medication, Diovan.

20 16. Valsartan is used to treat high blood pressure and heart failure, and to improve a patient's

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chances of living longer after a heart attack.

22 17. Valsartan is classified as an angiotensin receptor blocker (ARB) that is selective for the type

23 II angiotensin receptor. It works by relaxing blood vessels so that blood can flow more easily,

24 thereby lowering blood pressure.

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26 18. Valsartan can be sold by itself or as a single pill which combines valsartan with amlodipine or

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HCTZ (or both).

28 19. The drug binds to angiotensin type II receptors (AT1), working as an antagonist.

4 COMPLAINT AND DEMAND FOR JURY TRIAL

Case 1:19-cv-00212-LJO-SKO Document 1 Filed 02/12/19 Page 5 of 39

1 20. The patents for Diovan and Diovan/hydrochlorothiazide expired in September 2012.6

2 21. Shortly after the patent for Diovan expired, the FDA began to approve generic versions of the

3 drug.

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5

I. NDMA

6 22. N-nitrosodimethlyamine, commonly known as NDMA, is an odorless, yellow liquid.7

7 23. According to the U.S. Environmental Protection Agency, "NDMA is a semivolatile chemical

8 that forms in both industrial and natural processes."8

9 10 24. NDMA can be unintentionally produced in and released from industrial sources through

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chemical reactions involving other chemicals called alkylamines.

12 25. The American Conference of Governmental Industrial Hygienists classifies NDMA as a

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confirmed animal carcinogen.9

14 26. The US Department of Health and Human Services (DHHS) similarly states that NDMA is

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reasonably anticipated to be a human carcinogen.10 This classification is based upon DHHS's

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findings that NDMA caused tumors in numerous species of experimental animals, at several 17

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different tissue sites, and by several routes of exposure, with tumors occurring primarily in the

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liver, respiratory tract, kidney, and blood vessels.11

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23 expires-but-generic-valsartan-is-mia/#4b43eaf92833. 7 .

24 8

17_508.pdf. 25 9

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17_508.pdf. 10

27 15-17_508.pdf. 11

28 15-17_508.pdf.

5 COMPLAINT AND DEMAND FOR JURY TRIAL

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